lopinavir and ritonavir lopinavir and ritonavir tablet film coated
1 INDICATIONS AND USAGE Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: • Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)]. Lopinavir and ritonavir tablets are an HIV-1 protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients (14 days and older). (1)
camber pharmaceuticals, inc.
OVAL YELLOW H 70
H 70 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING
LOPINAVIR AND RITONAVIR film coated tablets USP are available in the following strengths and package sizes:
LOPINAVIR AND RITONAVIR Tablets USP, 200 mg/50 mg yellow film coated, ovaloid tablets debossed with ‘H’ on one side and ‘70’ on other side. Bottles of 60 tablets (NDC 31722-556-60) Bottles of 120 tablets (NDC 31722-556-12) Blister pack of 80 (8x10) Unit dose tablets (Alu-Alu) (NDC 31722-556-31) Blister pack of 80 (8x10) Unit dose tablets (Alu-PVC/PVdC) (NDC 31722-556-32) Recommended Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in original container or USP equivalent tight container (250 mL or less). For patient use: exposure of this product to high humidity outside the original container or USP equivalent tight container (250 mL or less) for longer than 2 weeks is not recommended.
LOPINAVIR AND RITONAVIR Tablets USP, 100 mg/25 mg yellow, capsule shaped, biconvex film coated tablets, debossed with ‘H’ on one side and ‘L7’ on other side Bottles of 60 tablets (NDC 31722-603-60) Bottles of 120 tablets (NDC 31722-603-12) Recommended Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in original container or USP equivalent tight container (100 mL or less). For patient use: exposure of this product to high humidity outside the original container or USP equivalent tight container (100 mL or less) for longer than 2 weeks is not recommended.
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